Aseptic transfer devices of the double-door type are already known. Purely by way of example, the devices known under the trademark BIOSAFE® and the sealed junction devices between a first chamber and a second chamber isolated from an external environment that are described in the document EP-A-0688020 can be cited.
The object of the invention is said first chamber of devices of this type. In the text as a whole, this chamber is most often called “chamber” or sometimes “first chamber” particularly to distinguish it from the other chamber of the junction device and of the transfer device, this other chamber being called “second chamber.” It is understood that the term “chamber” without any other details and the expression “first chamber” are synonyms and indicate the same object.
A first known chamber such as the one used in the biopharmaceutical field is typically stationary, rigid, and of relatively large size, and it comprises:                A structure that includes a closed wall that borders an inside space,        At least one opening—the diameter of which can typically be on the order of 10 to 40 centimeters—made in the wall and bordered by an annular flange whose outside surface is able to ensure the hermetically-sealed flattening onto itself of the outside surface of a second complementary flange that is part of the second chamber,        Removable holding means, at least partly combined with the flange, able to hold—in a removable way—the flange and the second flange that are flattened against one another by their outside surfaces,        A door supported by the structure by means of carrying means, of a mechanical, movable, or deformable nature, the panel of which is arranged and mounted so as to be able to be moved to be either in the closed state where it works with the flange while closing the opening or in the open state where it is separated from the flange and placed in the inside space while opening the opening, and whose outside surface is able to ensure the hermetically-sealed flattening onto itself of the outside surface of the panel of a second complementary door that is part of the second chamber,        Removable interlocking means at least partly combined with the door, able to hold—in a removable way—the panel and the second panel that are flattened against one another by their outside surfaces,        Movement actuation means able to move the panel, with which the second panel is interlocked, between its closed and open states, and means for monitoring the movement actuation means,        And, when the panel is in the open state, an entrance/exit space in/of the inside space, in the general shape of a truncated cylinder, cone, or pyramid, that extends into the inside space at least approximately axially from the opening and from the flange, able to make it possible to pass certain contents into/out of the inside space from one to the other of the two chambers.        
The second chamber is typically a movable container, disposable, at least partly flexible and of a smaller size, and it comprises the second wall equipped with the second opening bordered by the second annular flange that forms, on the one hand, an interface with the first flange, and, on the other hand, a seat for the second door whose panel is mounted for movement and arranged to be in the closed state or in the open state where, respectively, it closes or opens the second opening.
In the case of the embodiment known under the BIOSAFE® trademark, the carrying means and the movement actuation means of the first door and of its panel comprise a hinge whose axis—vertical and lateral—is located in the first chamber itself (the inside space of this first chamber), in or near the inside surface of its wall, near its opening and its flange, the pivoting around the hinge being performed manually or in a motorized way (actuator, motor . . . ). In the closed state, the panel is retracted in or in the vicinity of the plane of the wall, of the opening and of the flange. In the open state, the panel is projecting, in particular placed more or less perpendicularly to the plane of the wall, of the opening, and of the flange. The movement of the panel between its closed state and its open state (and vice versa) is on the order of one-third of a rotation. As for the movement actuation means, such as an actuator, motor . . . , they are able to move the panel to rotate on this course.
In the embodiments described in the document EP-A-2091051, where the axis is also vertical and lateral, in the documents EP-A-1 141 974, EP-A-1 454 328, EP-A-0 730 907, EP-A-0 830 896 where the axis is inferior horizontal (below the opening and the flange) and in the document EP-A-0 662 373, where the axis is superior horizontal, in the open state, the panel is also projecting and more or less perpendicular to the plane of the wall, the opening and the flange.
When the two chambers are in communication with one another through their respective openings in the open state, the entrance/exit space is part of a communication space between the two chambers that makes it possible to pass certain contents from one to the other of the two chambers and, thus, to transfer them from one chamber to the other.
In these embodiments, in the open state of the panel, the panel is laterally adjacent to the lateral boundary of the entrance/exit space, which can pose the problem that the panel is an impediment to the use of the sealed junction device and of the aseptic transfer device because a panel obstructs the passage of the certain contents from one of the two chambers to the other and, also, because the certain contents can reach the panel during their passage into the entrance/exit space, with risks of deterioration or contamination.
Transfers, such as those in question, can be necessary in a number of technical fields, particularly but not exclusively the biopharmaceutical field. The invention focuses especially on this field, as on those that can be considered as similar with regard to the requirements imposed.
Transfers, such as those considered here, occur most often in the framework of more complex processes in which the certain contents undergo one or more operations before and/or after the transfer. These operations consist in manufacturing, assembly, treatment, handling, use, measurement, monitoring, analysis, or the like . . . .
In the case of an operating line, a chamber can be provided that comprises a wall equipped with the same plurality of openings and doors, as well as sealed junction devices with a multiplicity of second chambers.
As document EP-A-1141672 states, one skilled in the art knows that with the type of aseptic transfer device under consideration, there exists what is called a “critical line” having residual contamination by the environment external to the two chambers. It is possible that this line comes into contact with the external environment that is found in the passage between the two chambers or into contact with the contents passing through this passage to be transferred from one chamber to the other, with, as a consequence, contamination. This critical line is sometimes called “critical zone” or “ring of concern” (see PIC/S—Pharmaceutical Inspection Convention—RECOMMENDATION—ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING).
An inside critical line is found on the outside surface of the first door, more precisely of its panel, in contact with the external environment and not overlapped by the outside surface of the second door, more precisely of its panel, when the two panels are flattened against one another. An outside critical line is found on the outside surface of the second flange in contact with the external environment and not overlapped by the outside surface of the first flange, when the two flanges are flattened against one another.
Embodiments such as those described in the documents EP-A-1 141 974, EP-A-1 454 328, EP-A-0 730 907, EP-A-0 830 896, EP-A-0 662 373 and EP-A-2091051 have as a drawback that in its open state, the panel is close to the opening of the chamber and of the entrance/exit space, so that the certain contents can reach the panel during their passage into the entrance/exit space, with the inherent risks of deterioration, contamination . . . .
Several solutions have been proposed for the purpose of overcoming the risk of contamination in the critical lines, a risk that is also mentioned in ISOLATION TECHNOLOGY—A PRACTICAL GUIDE, published by CRC Press in 2004.
The document EP-A-0960698 provides decontamination means using ultraviolet, pulsed-ultraviolet, or pulsed-light radiation. The document EP-A-0662373 provides that a flanged ring of the aseptic transfer device comprises a heat-resistant annular element. Variants of heating technology are described in the documents EP-A-730907 and EP-A-830907. The technology of sterilization by dry heat has been indicated as being the preferred solution according to the presentation made by the Barrier Users Group Symposium (BUGS) at the conference of Jan. 17 and 18, 1995. The document EP-A-1454328 describes an aseptic transfer device that comprises a device for protection of the single outside critical line.
The state of the art also comprises the documents U.S. Pat. No. 3,489,298, EP 0586307, EP 0 830896, WO 03/041087, WO 95/34078, FR2833745, FR 2787 235, US 2009/212054 and WO 96/21615. However, none of these documents provides for the chamber being such that:                On the one hand, the carrying means and the movement actuation means are arranged so that in the open state of the panel, the panel is substantially separated beyond the boundary of the entrance/exit space, and so that thus an empty separation space is made between the entrance/exit space and the panel in the open state, beyond the lateral boundary and the distal end boundary of the entrance/exit space opposite the opening and the flange;        And, on the other hand, the carrying means and the movement actuation means, structurally integrated into the door, constitute means for protection against the risks of contamination for the inside critical line, constituted by the separation space of appropriate size formed and placed between the entrance/exit space and the inside critical annular line, so that the certain contents normally cannot reach the panel during their passage into the entrance/exit space.        
The problem at the base of the invention is to equip a (first) chamber designed to be part of a sealed junction device and of an aseptic transfer device with a second chamber of a structure such that the (first) panel of the (first) door of the (first) chamber in the open state is not an impediment to the use of the sealed junction device and of the aseptic transfer device, particularly does not obstruct the passage of the certain contents from one to the other of the two chambers, especially the passage of the certain contents into the entrance/exit space of the first chamber, and also that the certain contents cannot reach the first panel during their passage into the entrance/exit space, with the advantage of overcoming the risks of deterioration or contamination when that is not the case. In other words, the invention aims at seeing to it that the entrance/exit space and the communication space are separated, which is particularly useful, for example, for the passage of certain powdered contents when a transfer cone is used.
Another aspect of the problem on which the invention is based is to produce a chamber whose opening has a diameter that is larger than the currently typical openings—on the order of 10 to 40 centimeters. Such a wider opening increases the obstruction problem previously mentioned.